In recent years, a growing number of laws and regulations have been adopted, many of them in the food safety arena, with a view to securing the food supply from a variety of threats. Their increase was fueled by a number of well-documented scandals (mentioned in previous journal articles) involving major brands, often due to breakdowns somewhere in their supply chain.
There’s no question, then, that there is a reason for the implementation of more reporting, and a finer “net” to catch products and processes out of compliance with best practices. In addition, new demands have been placed on companies based on the upgrading of “best practices” in various industries, pressure from competitors looking for an edge in the quality domain, and the emergence of new customer preferences.
As a result of these pressures, there is more work to do to stay in compliance, which we know is the minimum achievement in QA management. When the system is complex––that is, spread over multiple tiers and perhaps across national boundaries––making sure that it remains flawless at every link becomes a daunting task.
It’s Not Always about the Big Breakdown
It’s easy to see how an organization at any level or stage in a supply chain may become overwhelmed balancing the need for ideal compliance with labor issues, materials costs, and deadlines. These pressures may be unequal, even within the same company or same department. It may be only one department that is overwhelmed, but that is all it takes to launch sub-standard materials or components into the flow of supplies that may skid right into the market, doing irreparable harm to the brand, and worst of all, to people.
The critical problems are pockets of non-compliance, perhaps small areas that are overburdened by work, or under-managed from above due to other pressures, that may be the source of the biggest problems. This is what the increasing number of regulations hopes to address, by attempting to cauterize the afflicted channels.
What should a company do to secure its market and reputation in the face of these new pressures?
Access to Data
A close examination of the Food Safety Modernization Act* (FSMA) shows that many of the rules already adopted, and those still in process, relate to data, and the ability of a company to produce data upon demand. This goes beyond merely submitting routine documentation. For example, the adopted rule “Establishment, Maintenance, and Availability of Records: Amendment to Record Availability Requirements” states that:
The FSMA amendment expands FDA’s former records access authority beyond records relating to the specific suspect article of food to include records relating to any other article of food that FDA reasonably believes is likely to be affected in a similar manner. In addition, the FSMA amendment permits FDA to access records relating to articles of food for which FDA believes that there is a reasonable probability that the use of or exposure to the article of food, and any other article of food that FDA reasonably believes is likely to be affected in a similar manner, will cause serious adverse health consequences or death to humans or animals.
Responding to New Challenges
One possibility for responding to them is by taking the stance that regulation is an onerous imposition by an out-of-control bureaucracy. On the other hand, those who respond that way also have families who could be affected by an out-of-control food supply, or other kinds of dangerous products. Clearly, no responsible company would adopt this approach to responding to new regulations
Once the need for a robust system is accepted as reasonable, then a company must come to terms with successfully managing more documentation.
Many departments may be in involved in this type of management, including Quality, Regulatory Compliance, Product Engineering, and others. All are dealing with an increased flow of documentation, and a much greater demand for accessing data and making sense of it.
The question then is not how big the response should be, but at what level the response is mounted.
Simply dealing with a larger volume and increased complexity by overloading a system organized for a different era may diminish compliance performance and induce risk.
The price of that may carry these risks to the brand and reputation, to investors, and to customers.
Time to Rethink Your Strategy? The Compliance Champion
Since the theme of compliance, and the activities necessary to manage it, flows through a number of departments in a company, management may want to consider creating a new function, that of the “Compliance Champion.”
The Compliance Champion will orchestrate the compliance activities throughout the company. This includes making sure that all aspects of compliance are up to date in each area, but also making sure the system the company uses to manage documentation, and for accessing necessary data relating to compliance, is both affordable and state-of-the-art.
In addressing new regulations in your industry, such as the Food Safety Modernization Act*(in the food industry, for example) the Champion would be empowered to manage conversations inside the company, addressing questions such as the following:
- What is the real-world risk that the legislation is designed to mitigate?
- How does our product contribute to or mitigate that risk?
- What are the ethical ramifications of inadequate compliance in this area? What is our company mission about, as it relates to this area?
- What is the legal risk of non-compliance?
- What financial risks do we take if our compliance is less than 100% (Cost of (Poor) Quality)?
- After considering the above, how big an investment should we make to ensure our compliance?
- What is the most affordable, as well as the most reliable approach?
- What approach will allow us to be prepared for additional demands on our system that are likely to occur on a regular basis?
Companies learn key lessons from in their compliance breakdowns. The most important is that it is impossible to manage something that is not visible, not known. If substandard materials or unchecked documentation flowing from some pocket of compliance inactivity are to be stopped from wreaking havoc, they must first show up on someone’s dashboard as a risk.
One choice is to work harder and harder to make sure that products are made to specification, and that initial/ongoing qualification documentation is in compliance.
In fact, one client of GSQA was planning to hire fifty additional quality professionals to manage its compliance with regulations to satisfy customer demands. After a cost analysis, they chose to use GSQA, an affordable and effective solution for ensuring visibility and manageability of compliance activity throughout their supply chain.
The regulatory documentation required today across industries begs for a standard approach supported by technology, rather than manpower; one that ensures the robust supply chain quality protection that the regulations should provide all of us.